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Rznomics Gene Therapy-Based Anti-Cancer Candidate Approved by FDA for New Manufacturing Process
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- 작성자
- 관리자
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- 날짜
- 2024-02-06
Rznomics has changed the
manufacturing method of its anti-cancer candidate ‘RZ-001’, which is currently
in clinical trials. It has become possible to produce a sufficient amount of
clinical drug for high-concentration administration cost-effectively.
Rznomics announced on the 6th that it has received approval from the U.S. Food and Drug Administration (FDA) to use the newly manufactured RZ-001 in clinical trials.
Changes in the manufacturing method for drugs that have already entered clinical trials under the approval of the IND require approval from regulatory authorities. An Rznomics official said, "By implementing the new manufacturing method, we can obtain a greater quantity of finished pharmaceutical drugs at the same cost, allowing for more efficient conduct of clinical trials for safety and efficacy validation." They added, "The development of the new process was led by Rznomics rather than CDMO."
Rznomics' RZ-001 is currently undergoing clinical trials for hepatocellular carcinoma (HCC) and glioblastoma (GBM). Last month, it received Orphan Drug Designation(ODD) from the FDA for the treatment of hepatocellular carcinoma and was granted Fast Track status for glioblastoma.
Bo-mi Kim, head of Rznomics’ RA team, said, "From a regulatory perspective, the establishment of the new manufacturing method’s CMC(Chemistry, Manufacturing and Controls) will likely be significantly beneficial when considering Biologics License Application(BLA) submissions."
Seong-wook Lee, CEO of Rznomics, also emphasized, "The CMC(Chemistry, Manufacturing and Controls) is a crucial aspect to confirm during discussions with global partners for licensing agreements and it will serve as a highly positive factor from a business perspective."
Rznomics announced on the 6th that it has received approval from the U.S. Food and Drug Administration (FDA) to use the newly manufactured RZ-001 in clinical trials.
Changes in the manufacturing method for drugs that have already entered clinical trials under the approval of the IND require approval from regulatory authorities. An Rznomics official said, "By implementing the new manufacturing method, we can obtain a greater quantity of finished pharmaceutical drugs at the same cost, allowing for more efficient conduct of clinical trials for safety and efficacy validation." They added, "The development of the new process was led by Rznomics rather than CDMO."
Rznomics' RZ-001 is currently undergoing clinical trials for hepatocellular carcinoma (HCC) and glioblastoma (GBM). Last month, it received Orphan Drug Designation(ODD) from the FDA for the treatment of hepatocellular carcinoma and was granted Fast Track status for glioblastoma.
Bo-mi Kim, head of Rznomics’ RA team, said, "From a regulatory perspective, the establishment of the new manufacturing method’s CMC(Chemistry, Manufacturing and Controls) will likely be significantly beneficial when considering Biologics License Application(BLA) submissions."
Seong-wook Lee, CEO of Rznomics, also emphasized, "The CMC(Chemistry, Manufacturing and Controls) is a crucial aspect to confirm during discussions with global partners for licensing agreements and it will serve as a highly positive factor from a business perspective."
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- TEL. 031-706-8730
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